UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000033278
Receipt number R000037941
Scientific Title An exploratory before-after study to evaluate the efficacy of dietary supplement ingestion on changes in body composition
Date of disclosure of the study information 2018/07/11
Last modified on 2019/01/07 14:05:01

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Basic information

Public title

An exploratory before-after study to evaluate the efficacy of dietary supplement ingestion on changes in body composition

Acronym

Effects of dietary supplement intake on body composition

Scientific Title

An exploratory before-after study to evaluate the efficacy of dietary supplement ingestion on changes in body composition

Scientific Title:Acronym

Effects of dietary supplement intake on body composition

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the effectiveness of ingesting dietary supplement ingestion to athletes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Body composition

Key secondary outcomes

Exercise performance


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Protein jelly beverage

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

40 years-old >

Gender

Female

Key inclusion criteria

1) More than 20 years and less than 40 years old
2) Women's volleyball player belonging to the execution facility

Key exclusion criteria

1) Subjects with milk allergy and soybean allergy
2) Subjects who can not perform training
3) Subjects who are willing to become pregnant during the exam, pregnant, Breastfeeding
4) Subjects who are judged inappropriate for the study by the physician.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Hashimoto

Organization

Himeji Victorina Co., LTD.

Division name

President

Zip code


Address

43-Chome, Shimoteramati, Himeji-City, Hyogo-Pref.

TEL

079-278-2023

Email

info@victorina-vc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satomi Miyazaki

Organization

Himeji Victorina Co., LTD.

Division name

none

Zip code


Address

43-Chome, Shimoteramati, Himeji-City, Hyogo-Pref.

TEL

079-278-2023

Homepage URL


Email

info@victorina-vc.jp


Sponsor or person

Institute

Himeji Victorina Co., LTD.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 11 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 06 Month 28 Day

Date of IRB


Anticipated trial start date

2018 Year 07 Month 11 Day

Last follow-up date

2018 Year 10 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 07 Month 04 Day

Last modified on

2019 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037941


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name